Daratumumab Now FDA Approved for Newly Diagnosed Transplant-Ineligible Myeloma Patients

Daratumumab is now FDA approved in combination with lenalidomide and dexamethasone for newly diagnosed myeloma patients who are not eligible to receive a stem cell transplant.

Daratumumab was approved in the fall of 2015 and has been a very effective addition to the myeloma drug arsenal for patients. It was formerly approved for use after initial lines of treatment. This new FDA approval was based on results from the Phase III MAIA (MMY3008) clinical study which showed that the addition of daratumumab to lenalidomide and dex reduced the risk of disease progression or death by 44 percent compared with lenalidomide/dex alone.

The MAIA study included 737 newly diagnosed patients who were not eligible for a stem cell transplant. Patients either received dara/len/dex or len/dex and were kept on treatment until disease progression. Over 44% of the study participants were older than 75 years old, a common but difficult to treat population. The earlier use of daratumumab will be helpful for all patients, especially the elderly.

“Multiple myeloma can become more difficult to treat after relapse, so it is important that patients receive an efficacious upfront therapy with a goal of extending their first remission period,” said Saad Usmani, M.D., FACP, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Carolinas HealthCare System, and a lead investigator of the MAIA study. “This regimen offers an important frontline treatment option for this patient population, and it has been submitted to the NCCN Multiple Myeloma Panel for review and consideration for potential inclusion in the NCCN Clinical Practice Guidelines.”

The application received approval through the U.S. FDA’s Real-Time Oncology Review (RTOR) pilot program which aims to explore a faster review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality and balancing the review team’s workload through data and analysis standardization. 

Dr. Saad Usmani shares more about the MAIA trial results at the June ASCO meeting. He notes that dosing changes of lenalidomide may be required when used with daratumumab.

The safety profile was similar in this study as in past daratumumab studies. Serious adverse reactions with a 2 percent greater incidence in the DARALEX-Rd arm compared to the Rd arm were pneumonia (15 percent vs. 8 percent), bronchitis (4 percent vs. 2 percent) and dehydration (2 percent vs. <1 percent), respectively.

This is the 6th FDA approved use of daratumumab in multiple myeloma and is great news for patients.